Are compounding pharmacies regulated?

The New England Compounding Center is shown here on Oct. 5, 2012. Until the Framingham, Mass., pharmacy landed in the news for the 2012 fungal meningitis outbreak, a lot of folks hadn't heard of these specialized pharmacies.

Compounding pharmacies don't usually get a lot of media coverage for good news. It's the mistakes -- the deadly outbreaks of meningitis from contaminated vials or the eye infections caused by unsterile medications -- that tend to make the evening news. Turns out, though, that regulatory practices for compounding pharmacies, at least in the United States, tend to follow the same pattern. Until something goes wrong, safeguards aren't generally in place.

First off, let's briefly outline what one of these places is. In the U.S., most drugs and medications are manufactured by large pharmaceutical companies. That means most prescriptions come in bulk: only certain potencies, forms or methods. A compounding pharmacy, however, will create your medication from scratch. Usually that's done for specific reasons: For instance, someone maybe allergic to the red dye in a product, and a compounding pharmacy can mix a prescription that leaves out that inactive ingredient. People often turn to these pharmacists for veterinary needs: Anyone who's ever had to force a pill down a cat's gullet could understand why suspending the drug in a fish-flavored liquid ready for lapping might be a lot easier.

Keep Reading Below

But that ease might come at a price. As of 2012, these specialized pharmacies fell into a kind of gray area of regulation, with state pharmacy boards overseeing both them and regular pharmacies. The U.S. Food and Drug Administration, in turn, focuses more on the big pharmaceutical manufacturers. Sonia Gale, a compound pharmacy director in Washington state, points out that the setup doesn't necessarily cover the safety of a pharmacy.

"Very, very little is regulated by the state," Gale says of Washington state practices. That's because although the state is regulating, it's more concerned with liability issues than specific safety oversight. (That could have something to do with the fact that the state has little knowledge of manufacturing practices [source: Pittman and Smith]). It's left to the pharmacies to regulate their own safety practices and to uphold ethical obligations.

And how do they do that? Let's take a look at the next page to check out some professional organizations and accreditation that compounding pharmacies use to keep their facilities and products safe.